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Explorations of the Normal Neural Behavioral and Pathological Bases of Metacognition (METASENS)

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ClinicalTrials.gov Identifier: NCT03140475
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : July 28, 2021
Sponsor:
Collaborators:
Versailles Saint-Quentin-en-Yvelines University
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
Dr Paul ROUX, Versailles Hospital

Brief Summary:

Metacognition is the ability to introspect and report one's own mental states, or in other words to know how much one knows. It allows us to form a sense of confidence about decisions one makes in daily life, so one can commit to one option if our confidence is high, or seek for more evidence before commitment if our confidence is low. Although this function is crucial to behave adequately in a complex environment, confidence judgments are not always optimal. Notably, individuals with schizophrenia are prone to overconfidence in errors and underconfidence in correct answers. In schizophrenia, confidence is less correlated with performance compared to controls.

These aspects are held to be at the origin of delusions, disorganization, poor insight into illness and into cognitive deficit and poor social functioning.

Our study aims at identifying the cognitive and neural processes involved in metacognitive deficits in schizophrenia. Participants will perform metacognitive judgments on a low-level perceptual task (visual motion discrimination). Participants will do the first-order perceptual task by clicking on the correct answer with a mouse. During the first order task completion, the investigators will record several behavioral, physiological and neural variables. Then, participants will perform the metacognitive task with a visual analog scale.

The study will address four research questions:

  • Q1: is schizophrenia associated with a decrease in metacognitive efficiency? Is the metacognitive deficit due to under- or over-confidence?
  • Q2: is the metacognitive impairment reflected at a decisional level as measured by behavioral variables (mouse tracking and reaction times)?
  • Q3: which physiological markers (EEG, skin conductance, heart rate) are predictors of metacognitive efficiency in individuals with schizophrenia and healthy controls?
  • Q4: which clinical symptoms correlate with metacognitive deficits?

The investigators make several hypotheses related to the previous research questions:

  • Q1: the investigators expect metacognitive deficits in schizophrenia, based on results from several studies using both qualitative and quantitative measures. The investigators will rule out that quantitative deficits are not confounded with impairments in type 1 performance, with a generalized cognitive deficit in schizophrenia (lower premorbid and current Intelligence Quotient (IQ), and deficits in executive functioning and particularly in planning and working memory abilities), with depression or with statistical flaws during analysis of confidence.
  • Q2: the investigators expect behavioral cues (mouse tracking and reaction times) to be less correlated with confidence in patients vs. controls. The investigators thus make the hypothesis that the metacognitive deficit in schizophrenia may stem from an inability to integrate pre-decisional cues while performing an explicit metacognitive judgment.
  • Q3: the investigators expect physiological cues (EEG with Error-Related Negativity, Lateralized Readiness Potential and alpha suppression, and arousal of the autonomic nervous system with skin conductance and heart rate ) to be less correlated with confidence in patients vs. controls.
  • Q4: based on previous findings, the investigators expect that several clinical dimensions of schizophrenia may correlate with metacognitive performance. The metacognitive deficit would be greater for patients with high levels of positive and disorganized symptoms, and greater for patients with low levels of clinical and cognitive insight, and low levels of social functioning.

Condition or disease
Schizophrenia Insight Impaired Social Skills Behavior

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Explorations of the Normal Neural Behavioral and Pathological Bases of Metacognition
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : July 27, 2022
Estimated Study Completion Date : September 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
Individuals with schizophrenia

Behavioral variables:

Type 1 task (motion discrimination) accuracy (binary: correct/incorrect) / Type 1 reaction time (continuous: time to respond to the type 1 task in ms) / Confidence (continuous: visual analog scale) / Type 2 reaction time (continuous: time to report confidence in ms) / Mouse trajectory (pixel coordinates)

Physiological variables:

Electroencephalogram (continuous: 64ch. time-locked to type 1 response) / Heart rate (continuous: time-locked to type 1 response) / Galvanic skin response (continuous: time-locked to type 1 response)

Clinical variables:

Positive and Negative Syndrome Scale / Birchwood Insight Scale / Beck Cognitive Insight Scale / Personal and Social Performance Scale / Calgary Depression Scale / Chlorpromazine equivalents

Neuropsychological variables:

National Adult Reading Test (French) / Wechsler Adult Intelligence Scale version IV (WAIS-IV) subtests (matrix reasoning, vocabulary, letter-number sequencing)

Controls

Behavioral variables:

Type 1 task (motion discrimination) accuracy (binary: correct/incorrect) / Type 1 reaction time (continuous: time to respond to the type 1 task in ms) / Confidence (continuous: visual analog scale) / Type 2 reaction time (continuous: time to report confidence in ms) / Mouse trajectory (pixel coordinates) /

Physiological variables:

Electroencephalogram (continuous: 64ch. time-locked to type 1 response) / Heart rate (continuous: time-locked to type 1 response) / Galvanic skin response (continuous: time-locked to type 1 response) /

Clinical variables:

Calgary Depression Scale

Neuropsychological variables:

National Adult Reading Test (French) / WAIS-IV subtests (matrix reasoning, vocabulary, letter-number sequencing)




Primary Outcome Measures :
  1. Metacognitive performance [ Time Frame: Repeated measures within a 2 hours long experiment ]
    Regression slope between accuracy and confidence, in a binomial mixed-effects model including appropriate covariates (variables that are significantly different between patients and controls, among the following: age, sex, education, premorbid and current IQ, executive performance with planning and working memory; and depression)

  2. Predecisional behavioral variables [ Time Frame: Repeated measures within a 2 hours long experiment ]
    Reaction times and mouse trajectory parameters (motion entropy on the x-axis)

  3. EEG markers [ Time Frame: Repeated measures within a 2 hours long experiment ]
    Error-Related Negativity, Lateralized Readiness Potential and alpha suppression


Secondary Outcome Measures :
  1. Metacognitive bias [ Time Frame: Repeated measures within a 2 hours long experiment ]
    Asymptote of the regression line between accuracy and confidence, in a binomial mixed-effects model including appropriate covariates (variables that are significantly different between patients and controls, among the following: age, sex, education, premorbid and current IQ, executive performance with planning and working memory; and depression)

  2. Positive symptoms of schizophrenia [ Time Frame: One measure per subject, assessed during a 30 min long interview ]
    The following items of the the Positive and Negative Syndrome Scale: P1+P3+G9+P6+P5+G1+G12+G16-N5

  3. Disorganization symptoms of schizophrenia [ Time Frame: One measure per subject, assessed during a 30 min long interview ]
    The following items of the the Positive and Negative Syndrome Scale: N7+G11+G10+P2+N5+G5 +G12 +G13 +G15+G9

  4. Insight into illness [ Time Frame: One measure per subject, assessed with a 10 min long autoquestionnaire ]
    Total score on the Birchwood Insight Scale, a self-report scale with 8 items

  5. Cognitive insight [ Time Frame: One measure per subject, assessed with a 20 min long autoquestionnaire ]
    Total score on the Beck Cognitive Insight Scale, a self-report scale with 15 items

  6. social functioning [ Time Frame: One measure per subject, assessed during a 20 min long interview ]
    Total score on the Personal and Social Performance Scale


Other Outcome Measures:
  1. Heart rate [ Time Frame: Repeated measures within a 2 hours long experiment ]
    Measured with a Gtec plethysmographic pulse sensor

  2. Galvanic skin response [ Time Frame: Repeated measures within a 2 hours long experiment ]
    Measured with a Gtec dedicated sensor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients:

Patients will be stabilized and will be recruited from community mental health centers and outpatient clinics in the Versailles area and among the FACE-SZ (FondaMental Academic Centers of Expertise for Schizophrenia) cohort in Versailles.

Controls:

Healthy volunteers will be recruited from the general population. The control group will be screened for current or past psychiatric illness and participants will be excluded if they meet criteria for any disorder of the DSM-V

All participants will be naive to the purpose of the study, give informed consent in accordance with institutional guidelines and the Declaration of Helsinki, and receive a monetary compensation (10€ / h).

Criteria

Inclusion Criteria:

  • DSM-V criteria for schizophrenia (Structured Clinical Interview for Disorders)
  • Normal or corrected-to-normal vision

Exclusion Criteria:

  • a moderate or severe substance used disorder within the past 6 months (DSM-V criteria)
  • current or prior history of untreated significant medical illness or of neurological illness
  • electroconvulsive therapy in the last three months
  • dyschromatopsia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140475


Contacts
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Contact: Paul ROUX, Psychiatrist +33 1 39 63 93 80 proux@ch-versailles.fr
Contact: Amina CATTENOY, Project Manager +33 1 39 23 97 77 acattenoy@ch-versailles.fr

Locations
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France
CHU Grenoble Not yet recruiting
Grenoble, France
Contact: POLOSAN Mircea         
Centre Hospitalier de Versailles Recruiting
Le Chesnay, France, 78150
Contact: Paul Roux, MD PhD         
CH Alpes Isère Not yet recruiting
Saint-Égrève, France
Contact: DUBREUCQ Julien         
Sponsors and Collaborators
Versailles Hospital
Versailles Saint-Quentin-en-Yvelines University
Centre National de la Recherche Scientifique, France
Investigators
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Principal Investigator: Paul ROUX, MD PhD Versailles Hospital
Publications:
Fox, J. (2003). Effect displays in R for generalised linear models. Journal of statistical software 8(15): 1-27.
Kieslich, P. J., D. U. Wulff, et al. Mousetrap: An R package for processing and analyzing mouse-tracking data (Version 3.0.0). 2017
Kuznetsova, A., P. B. Brockhoff, et al. Package 'lmerTest'. R package version 2. 2015
Morey, R. D., J. N. Rouder, et al. BayesFactor: Computation of Bayes factors for common designs. R package version 0.98. 2014.
Singmann, H., B. Bolker, et al. afex: Analysis of factorial experiments. R package version 0.15-2. 2015.
Team, R. C.R: A language and environment for statistical computing. Vienna: R Foundation for Statistical Computing. 2016.
Wickham, H. ggplot2: elegant graphics for data analysis, Springer. 2016.

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Responsible Party: Dr Paul ROUX, Investigator coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03140475    
Other Study ID Numbers: P16/25_METASENS/METACTION
2016-A01612-49 ( Other Identifier: ANSM )
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Paul ROUX, Versailles Hospital:
Metacognition
Mousetracking
EEG
Event related potentials
Frequency analysis
Depression
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders